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临床试验/NCT00236340
NCT00236340已完成不适用

DRAINAGE AMNIOTIQUE A LA SERINGUE OU PAR ASPIRATION CONTINUE DANS LES HYDRAMNIOS SYMPTOMATIQUES. ETUDE PROSPECTIVE RANDOMISEE.

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2002年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
maternal pain (Analogic visual scale)

研究概览

简要总结

To compare the efficiency and maternal and fetal tolerance of two techniques of amnioreduction used in cases of symptomatic second and third trimester polyhydramnios: syringe manual aspiration technique (S group) and continuous suction technique (C group) set to - 250 mmHg

详细描述

Polyhydramnios is defined as more than 2 liters of amniotic fluid. Ultrasound diagnosis is made either by measurement of a deepest vertical pocket exceeding 8 cm, or by use of an amniotic fluid index (AFI) exceeding 25 cm. Potential complications of polyhydramnios are preterm labor, premature rupture of membranes, altered utero-placental perfusion, and maternal discomfort.

Amniodrainage has become an established technique to improve maternal comfort and reduce the risks of severe polyhydramnios in both singleton and twin pregnancies, decreasing uterine contractility, as well as over-stretching of membranes and uterus. It also acts on the pathological processes of twin to twin transfusion syndrome.

Several techniques are used to reduce symptomatic polyhydramnios. Passive gravitational drainage is long, does not allow to evacuate larger amounts of amniotic fluid and continuous maternal and fetal monitoring is difficult. The standard syringe technique is often a source of discomfort for both the patient and the operator. Continuous aspiration is faster and limits patient's discomfort.

The aim of this study was to compare the efficiency and maternal and fetal tolerance of these two latter techniques of amnioreduction.

A preliminary study permitted to assess the depression value created at the tip of the needle during amniodrainage: the syringe aspiration technique showed large depression variations from 0 to - 300 millimeters of mercury (mmHg). The continuous wall suction was thus chosen to be set to - 250 mmHg: depression at the needle's tip didn't vary during the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with abdomen discumfort and ultrasound diagnosis of polyhydramnios (AFI>25cm)
  • Single or twin pregnancies

排除标准

  • Multiple pregnancy (more than 3 fetuses)
  • Maternal history of placental abruptio
  • Fetus with IUGR
  • Pregnancy complicated with pre-eclampsia
  • Unability to give informed consent

结局指标

主要结局

maternal pain (Analogic visual scale)

时间窗: After drainage

次要结局

  • Volume of amniotic fluid drained(After drainage)
  • Duration of the drainage(After drainage)
  • Uterine activity(After drainage)
  • Recording of Foetal Heart Rate(After drainage)
  • Clinical Retroplacental Haematome(After drainage)
  • Histological analysis of the placentas(After drainage)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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